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Reducing Falls With RENEW in Older Adults Who Have Fallen

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ClinicalTrials.gov Identifier: NCT01080196
Recruitment Status : Completed
First Posted : March 3, 2010
Results First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Collaborators:
Department of Health and Human Services
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Paul LaStayo, University of Utah

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Muscle Atrophy
Physical Deconditioning
Intervention: Behavioral: RENEW

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
RENEW RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a “target” workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE.
TRADITIONAL The TRAD group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their multicomponent exercise fall reduction program (MCERFP). The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (1RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A “target” resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period.

Participant Flow:   Overall Study
    RENEW   TRADITIONAL
STARTED   68   66 
COMPLETED   68   66 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
RENEW RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a “target” workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE.
TRADITIONAL The TRAD group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their MCERFP. The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A “target” resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period.
Total Total of all reporting groups

Baseline Measures
   RENEW   TRADITIONAL   Total 
Overall Participants Analyzed 
[Units: Participants]
 68   66   134 
Age 
[Units: Years]
Mean (Standard Deviation)
 76.59  (7.39)   75.59  (6.98)   76.1  (7.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      45  66.2%      42  63.6%      87  64.9% 
Male      23  33.8%      24  36.4%      47  35.1% 
Region of Enrollment 
[Units: Participants]
     
United States   68   66   134 


  Outcome Measures

1.  Primary:   The Number of Days Survived Without a Fall Over the 1 Year Duration of the Study   [ Time Frame: 12 months ]

2.  Other Pre-specified:   Thigh Lean Tissue Cross Sectional Area (CSA) (cm^2)   [ Time Frame: 12 months ]

3.  Other Pre-specified:   Leg Extension Power (W)   [ Time Frame: 12 months ]

4.  Other Pre-specified:   Activities Specific Balance Confidence (ABC) (%)   [ Time Frame: 12 months ]

5.  Other Pre-specified:   Six Minute Walk Distance (6 MW) (m)   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Paul LaStayo
Organization: University of Utah
phone: 8019719298
e-mail: paul.lastayo@health.utah.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Paul LaStayo, University of Utah
ClinicalTrials.gov Identifier: NCT01080196     History of Changes
Other Study ID Numbers: 26292
R01AG031255-01A1 ( U.S. NIH Grant/Contract )
First Submitted: March 2, 2010
First Posted: March 3, 2010
Results First Submitted: March 22, 2016
Results First Posted: January 10, 2018
Last Update Posted: January 10, 2018